Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Stryker Trauma GmbH, FSN-PFA 2644769, Nail Insertion Sleeve, elastic T2 Tibia SPI

   The purpose of this notification is to advise you that Stryker Trauma GmbH is conducting a voluntary recall for the Nail ...

   Waarschuwing | 20-05-2021

2. Medtronic Sofamor Danek USA, Inc., FSN-FA973, Break-off set screw

   Medtronic is voluntarily recalling two lots of the Braive™ Break off Set Screw that are impacted by a thread profile defect due ...

   Waarschuwing | 30-04-2021

3. TEQUIR S.L., FSN-TQFSCA21001, TRIAL SPACER

   Tequir is conducting a medical device Field Safety corrective Action (return and device modification) for only one manufactured ...

   Waarschuwing | 16-04-2021

4. Arthrex INC, FSN-R525_NL, Tibial Opening Wedge Osteotomy Plate, Titanium, 15

   Deze veiligheidsmededeling is bedoeld om u te informeren over een terugroeping van de Arthrex Tibial Opening Wedge ...

   Waarschuwing | 31-03-2021

5. AesculapAG, FSN-FSCA254, Unimax

   Aesculap AG meldt Field Safety over Unimax; CE mark was applied without valid declaration of conformity.

   Waarschuwing | 22-03-2021

6. DePuy Ireland, FSN-1932449, MBT Cemented Keel Tibial Base 2)ATTUNE® FB AND RP

   DePuy (Ierland) UC heeft een vrijwillige recall actie geïnitieerd voor 37 lotnummers voor MBT & ATTUNE (S +) Tibia Tray vanwege ...

   Waarschuwing | 26-02-2021

7. Biomet France SARL,FSN-ZFA 2020 00418, T.E.S.S. (Total Evolutive Shoulder System)

   As a precautionary measure Biomet France SARL is conducting a medical device Field Safety Corrective Action(removal) for certain ...

   Waarschuwing | 18-02-2021

8. MEDARTIS AG FSCA-2020-001 - MODUS and MODUS 2 Pliers

   The previous information contained in the IFU was not specific enough for the following pliers: - M2-2016 2.0-2.5 Three-Point ...

   Waarschuwing | 17-12-2020

9. Zimmer Biomet ZFA 2020-00331 - Vanguard 360 Revision System

   As a precautionary measure Biomet Orthopedics LLC is conducting a medical device Field Safety Corrective Action (Removal) for a ...

   Waarschuwing | 16-12-2020

10. Synthes GmbH, FSN-1882308, RIA 2 (Reamer Irrigator Aspirator)

    Synthes GmbH initieert een vrijwillige veiligheidsmededeling voor alle lotnummers van de RIA 2 (Reamer Irrigator Aspirator 2).

    Waarschuwing | 20-11-2020